White House, HHS Defend Announcing Booster Shot Plan Ahead of Approval

By Nick Ciolino
Nick Ciolino
Nick Ciolino
Nick Ciolino covers the White House.
September 17, 2021 Updated: September 17, 2021

The White House and federal health officials are standing by the decision to announce the plans for COVID-19 booster shots for many Americans back in August ahead of the Food and Drug Administration’s (FDA) and Center for Disease Control and Prevention’s (CDC) approval for the extra doses.

The announcement issued by eight top government doctors on Aug. 18 notes clear evidence the COVID-19 vaccine effectiveness decreases over time and reveals a plan to roll out booster shots in response. The Biden administration then laid out plans to begin giving booster shots to more Americans starting Sept. 20.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met Friday morning to discuss whether booster doses will be recommended. It voted 16–3 against providing the booster for most people, but recommended it for those over 65 years old and those at high risk. The CDC Advisory Committee on Immunization Practices (ACIP) will hold a two-day meeting next week to make its recommendation.

The decision to make the announcement in August has raised questions of whether the White House and the Department of Health and Human Services (HHS) put undue pressure on the regulatory agencies to approve boosters by making the potential need for a third dose public.

U.S. Surgeon General Dr. Vivek Murthy said Friday the announcement was made for two reasons: transparency and planning.

“If we saw a signal that indicated to us that protection was starting to wane and that additional shots might be required, that we would be transparent and open to the public about that,” said Vivek, adding, “You want to roll out booster shots to the population. You can’t flip a switch and make that happen overnight. There’s important planning that needs to take place.”

The White House also backed the August announcement this week when press secretary Jen Psaki told reporters: “Our objective is to be prepared should all of this process move forward. It’s always been pending the approval of the ACIP and the FDA.”

The recent resignation of top vaccine officials within the FDA seems to suggest stark disagreement within the regulatory agency on the plan to roll out booster shots. Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, announced late last month their plans to leave the FDA in October and November.

The two were co-authors on a paper released this week in the scientific journal The Lancet saying that booster shots may only be appropriate for certain at-risk populations.

The article reads, “although the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects … If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

Officials say there is plenty of supply of boosters should they be approved.

Nick Ciolino
Nick Ciolino covers the White House.